Single Ascending Dose Study of Lu AF76432 in Healthy Youn... | NCT03531229

Studies
Single Ascending Dose Study of Lu AF76432 in Healthy Young Men

NCT03531229

Sponsor

H. Lundbeck A/S

Status

Completed

Last Update Posted

Apr 12, 2019Actual

Enrollment

42Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Placebo
Lu AF76432

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 17, 2018Actual

Primary Completion Date

Feb 22, 2019Actual

Completion Date

Feb 22, 2019Actual

First Submitted Date

Apr 20, 2018

First Submission Date that Met QC Criteria

May 8, 2018

First Posted Date

May 21, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2019

Last Update Posted Date

Apr 12, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to investigate safety, tolerability and pharmacokinetics of the drug Lu AF76432 given as single oral ascending doses to healthy young men

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo to Lu AF76432	Drug: Placebo
Lu AF76432	Experimental	Lu AF76432	Drug: Lu AF76432

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo to Lu AF76432 oral solution	Placebo
Lu AF76432

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with Treatment-Emergent Adverse Events	Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination)	From dosing to 12 days

Secondary Outcomes

Measure	Description	Time Frame
AUC0-t	Area under the plasma concentration-time curve from zero to time t	From dosing to 72 hours post dose
Cmax	Maximum observed concentration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-Healthy young non-smoking men ≥18 years of age and ≤45 years of age at the Screening Visit and a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit.

Exclusion Criteria:

The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder or the subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason
The subject has taken any investigational medicinal product <3 months prior to the first dose of IMP

Other inclusion and exclusion criteria may apply

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Email contact via H. Lundbeck A/S	LundbeckClinicalTrials@Lundbeck.com	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Parexel Early Phase Clinical Unit		Harrow			United Kingdom

Intervention Model Description

36 Subjects are planned for enrolment, with 6 subjects per cohort. The subjects will be randomized to Lu AF76432 or placebo in a 4:2 ratio per cohort. A maximum of 2 additional cohorts of young healthy men will be permitted thereby allowing investigation of a maximum of 48 subjects